Randomized trial comparisons

CanbakanB, SenturkH, TabakF, Akdogan M, Tahan V, Mert A, Sut N, Ozaras R, Midilli K, Ozbay G (2006) Efficacy of interferon alpha-2b and lamivudine combination treatment in comparison to interferon alpha-2b alone in chronic delta hepatitis a randomized trial. J Gastroenterol Hepatol 21 657-663... 

Elewski B, Fleischer AB, Pariser DM (2003) A comparison of 15% topical azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papu-lopustular facial rosacea results of a randomized trial. Arch Dermatol 139 1444-1450... 

The most important evidence is probably offered by a recent double-blind, randomized trial which showed a better therapeutic effect of rifaximin in comparison to tetracycline in a cohort of SIBO syndrome patients [42] in particular, rifaximin administration produced a significant reduction of breath hydrogen levels in fasting conditions, peak of hydrogen excretion and cumulative breath hydrogen excretion after an oral dose of 50 g of glucose (fig. 1). Normalization of the test results was evident in 70% of the sample studied. 

Howell A, Robertson JFR, Abram P, Lichinitser MR, Elledge R, Bajetta E, Watanabe T, Morris C, Webster A, Dimery I, et al. (2004a) Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy a multinational, double-blind, randomized trial. J Clin Oncol 22 1605-1613... 

Randomized controlled trials comparison with current 250-1000 +... 

The International Atomic Energy Agency is completing a large, randomized trial of the role of mitomycin in head and neck malignancies. Yale University continues to evaluated the possible superiority of porfiromycin (methyl mitomycin) in comparison to mitomycin in a randomized trial of greater than 120 HNC patients. Final results have yet to be published. 

A preliminary report on a randomized trial on 83 stage III or IV locally advanced squamous cell head and neck cancer (SCHNC) patients demonstrated improved 2-yr disease-free survival (65% vs 41%, p = 0.01) and increased rate of local control (85% vs 59%, p < 0.05) in the concomitant chemoradiation group (cisplatin 50 mg/m2 weekly) in comparison to radiation therapy alone (25). It should be noted that the DFS was improved overall in the concomitant arm despite 18% patients receiving only two-thirds of their scheduled dose of cisplatin as a result of nausea and vomiting. Mature results from this study have not been published to date. 

Keller S, Adak S, Fossella F, et al. Randomized prospective comparison of adjuvant mediastinal radiation with or without concurrent chemotherapy with cisplatin and etoposide for patients with completely resected T1-3N1-2M0NSCLC US intergroup lung trial 0115. Proc Am Soc Thera Rad Oncol (ASTRO). IJROBP 45, 1999 (abstr). 

Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES et al. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators the OPTIC Study a randomized trial. JAMA 2006 295 165-71. 

Thunainen A, Wahlbeck K, and Gilbody S. Newer atypical antipsychotic medication in comparison to clozapine A systematic review of randomized trials. Schizophr Res 2002 56 1-10. 

C.Y.C. Pak, K. Sakhaee, N.H. Bell, A. Licata, C. Johnston, B. Dubin, S. Bonnick, V. Piziak, H. Graham, J. Ballard, R. Berger, W. Fears, N. Breslau, C. Rubin, B. Adams-Huet, Comparison of non- randomized trials with slow-release sodium fluoride with a randomized placebo-controlled trial in postmenopausal osteoporosis, J. Bone Miner. Res. 11 (1996) 160-168. 

Janicak et al. (113, 283) recently reported the results of a double-blind, randomized trial of risperidone monotherapy versus haloperidol monotherapy for controlling both psychotic and mood symptoms in 62 patients with schizoaffective disorder (bipolar or depressed subtype). These authors observed that, in comparison with haloperidol, risperidone was as follows ... 

Packer M et al Comparison of omapatrilat and enalapril in patients with chronic heart failure The Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). Circulation 2002 106 920. [PMID 12186794]... 

Two recent reviews have assessed the efficacy of echinacea for this primary indication. A review by the Cochrane Collaboration involved 16 randomized trials with 22 comparisons. Trials were included if they involved monopreparations of echinacea for cold treatment or prevention. Prevention trials involving rhinovirus inoculation versus natural cold development were excluded. Overall, the review concluded that there was some evidence of efficacy for the aerial (above ground) parts of E purpurea plants in the early treatment of colds but that efficacy for prevention and for other species of echinacea was not clearly shown. Among the placebo-controlled comparisons for cold treatment, echinacea was superior in nine trials, showed a positive trend in one trial, and was insignificant in six trials. 

Saleh WA, Burkman RT, Zacur HA, Kimball AW, Kwiterovich P, Bell WK. A randomized trial of three oral contraceptives comparison of bleeding patterns by contraceptive types and steroid levels. Am J Obstet Gynecol 1993 168(6 Pt l) 1740-5. 

Aranda JM, Jr, Schofield RS, Pauly DF, et al. Comparison of dobutamine versus milrinone therapy in hospitalized patients awaiting cardiac transplantation a prospective, randomized trial. Am Heart J. 2003 145 324-329. 

Stone GW, Grines CL, Cox DA, et al, Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med 2002 346 957. Antoniucci D, Rodriguez A, Hempel A, et al, A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction, J Am Coll Cardiol 2003 42 1879. 

Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary intervention for ST-elevation myocardial infarct quantitative review of randomized trials. Lancet 2006 367 579-588.1... 

Differences in response rates were substantial in small studies, and especially between single-institution and large cooperative group trials. The major reason for these discrepancies is attributed to selection of patients for study those entered in single-institution studies tended to have better performance status and perhaps to have less extensive disease. These conclusions were reinforced by a comparison of the NCI Canada study that demonstrated a survival advantage for chemotherapy over best supportive care with two other randomized trials that failed to show such a difference. The negative trials included patients with performance status of 2, while the NCI... 

With the newest ARB, olmesartan, a comparison with starting doses of losartan 50 mg, irbesartan 150 mg, and valsartan 80 mg, in a prospective randomized trial, showed a significantly greater reduction in DBP (11.5 mmHg) with olmesartan, followed by the other three ARBs (8.2,9.9, 7.9 mmHg, respectively). Olmesartan appeared to have a greater dose-dependent blood pressure-lowering effect than irbesartan or candesartan, followed by losartan, telmisartan, and valsartan [29]. 

The justification for randomized trials is not that no worthwhile observations can be made without them, but that important biases can occur in non-randomized comparisons which are particularly problematic if the benefits of treatment are, in reality, small or absent. For example, a non-randomized comparison of the effect of aspirin dosage on the operative risk of carotid endarterectomy (Table 18.2) reported a clinically and statistically significant lower operative risk in patients on high-dose aspirin (1300 mg) than taking low-dose aspirin (325 mg or less) (Barnett et al. 1998) however, a subsequent randomized trial (Taylor et al. 1999), performed to confirm this observation, showed that high-dose aspirin was, in fact, harmful (Table 18.1). It is likely that the non-randomized comparison had been biased by unmeasured differences between the patients in the low-dose and high-dose aspirin groups. 

Nucci M, Loureiro M, Silveira F, Casali AR, Bouzas LF, Velasco E, Spector N, Pulcheri W. Comparison of the toxicity of amphotericin B in 5% dextrose with that of amphotericin B in fat emulsion in a randomized trial with cancer patients. Antimicrob Agents Chemother 1999 43(6) 1445-8. 

Solomon D, Schiffman M, Tarone R, Comparison of three management strategies for patients with atypical squamous cells of undetermined significance baseline results from a randomized trial. J Natl Cancer Inst 2001 93 293-9. 

Hudak ML, Martin DJ, Egan EA, et al. A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant... 

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